Impact of Marking Surgical Incision on Patient's Abdomen

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Florida Hospital
Sponsor:
Information provided by (Responsible Party):
Florida Hospital
ClinicalTrials.gov Identifier:
NCT01803334
First received: February 28, 2013
Last updated: March 1, 2013
Last verified: February 2013
  Purpose

This is a study looking at patient's satisfaction with incision site and location after undergoing minimally invasive gynecologic surgery. (Laparoscopy) The study group will have the anticipated incision marked with a washable marker on their abdomen. The control group will have preoperative counselling as usual. After surgery, will assess patient's satisfaction with the incision scar.


Condition Intervention
Surgical Procedure
Other: Marking abdomen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Impact of Marking Surgical Incision Size and Location on the Patient's Abdomen During Preoperative Counseling in Minimally Invasive Gynecologic Surgery. A Randomized Control Trial.

Further study details as provided by Florida Hospital:

Primary Outcome Measures:
  • Patient's expectation and satisfaction with incision scar will be evaluated with the patient scar assessment questionnaire and a 5 points Likert type scale question. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: June 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Marking abdomen
If the patient is randomized to the marking the abdomen group (study group) she will then have the anticipated incision needed to place the trocars during her surgery marked on her abdomen by the surgeon attending physician involved in the patient care during the preoperative counseling visit.
Other: Marking abdomen
If the patient is randomized to the marking the abdomen group (study group) she will then have the anticipated incision needed to place the trocars during her surgery marked on her abdomen by the surgeon attending physician involved in the patient care during the preoperative counseling visit.
No Intervention: Control
If she is randomized to the control group, then she will undergo traditional preoperative counseling by the same team without marking the abdomen.

Detailed Description:

This study is a prospective, randomized controlled trial examining the impact of marking the patient abdomen at the time of the preoperative visit on patient's satisfaction with scar appearance and symptoms, and pain at the incision site after undergoing minimally invasive gynecologic surgery for benign conditions.

We hypothesize that preoperative marking and instruction about incision expectations will improve patient's postoperative satisfaction with scar appearance and symptoms as well as decrease incision site pain compared to traditional preoperative counseling.

Patients that will undergo laparoscopic surgical intervention will be identified. The patient will be randomized into two groups: preoperative marking the abdomen versus conventional preoperative counseling.

If the patient is randomized to the marking the abdomen group (study group) she will then have the anticipated incision needed to place the trocars during her surgery marked on her abdomen by the surgeon attending physician involved in the patient care during the preoperative counseling visit. If she is randomized to the control group, then she will undergo traditional preoperative counseling by the same team without marking the abdomen.

After completed the surgery, information regarding type of surgery, reason for the procedure, estimated blood loss, surgical length, complications, location and size of abdominal incisions made on the patient's abdomen will be collected. Then at the 6 weeks post op visit, patient's satisfaction with the incision scar will be evaluated with a validated patient scar assessment questionnaire form and by one 5 point Likert scale question used in previous studies. The pain at rest at the incision site will be evaluated by a Visual Analog Pain Scale (VAS). Patients will also be asked to evaluate their generalized pain using a modified McGill Present Pain Intensity Scale.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 - 89
  2. Diagnosed with a benign surgical pathology
  3. Patient scheduled for elective minimally invasive gynecologic surgery

Exclusion Criteria:

  1. Have a diagnosis of gynecologic cancer
  2. History of prior laparoscopic surgery
  3. Emergency surgery
  4. Inability to provide informed consent
  5. Unable to follow up in the office for post operative visits
  6. Skin hypersensitivity or allergy to marker dye
  7. Positive pregnancy test
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803334

Contacts
Contact: Jose A Carugno, MD (407) 303-2780 jose.carugno.md@flhosp.org
Contact: Katerina Capote (407) 303-2780 katerina.capote@flhosp.org

Locations
United States, Florida
Florida Hospital Recruiting
Orlando, Florida, United States, 32804
Contact: Jose A Carugno, MD    407-303-2780    jose.carugno.md@flhosp.org   
Principal Investigator: Jose A Carugno, MD         
Sponsors and Collaborators
Florida Hospital
Investigators
Principal Investigator: Jose A carugno, MD Florida Hospital
  More Information

No publications provided

Responsible Party: Florida Hospital
ClinicalTrials.gov Identifier: NCT01803334     History of Changes
Other Study ID Numbers: 322259
Study First Received: February 28, 2013
Last Updated: March 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Florida Hospital:
surgical incision
laparoscopy
pain

ClinicalTrials.gov processed this record on September 18, 2014